I've just returned from Europe, where I spoke with various think tanks, thought leaders, and pharmaceutical companies on the issue they call "information-to-patients" (ItP). That's what we on the other side of the pond refer to as direct-to-consumer communications. In Europe, they choose to abstain from using the "A" word—advertising. But rhetoric counts. "Information to patients" seems quite paternalistic when compared with the new-worldly "direct-to-consumer" moniker.
Allowing the private sector to bear both the risk and the reward for successfully developing pharmaceutical, biologic, and medical technology products has been, and remains, the most successful, efficient way to meet our public health goals.
At FDA, science rules. Decisions are based on facts. But even facts require interpretation, and that task is done with verve, excellence, and dedication by the agency's world-class experts. But what about social science? How does the Division of Drug Marketing, Advertising, and Communications (DDMAC) engage social science to interpret vague concepts such as "fair balance" and "adequate provision"? The answer is that they know it when they see it-on a case-by-case basis. In common parlance, this is known as "judgment."